Siemens Healthcare Diagnostics - FDA 510(k) Cleared Devices
92
Total
92
Cleared
0
Denied
92 devices
Cleared
Feb 12, 2010
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
Chemistry
80d
Cleared
Jan 26, 2010
MICROSCAN MICROSTREP PLUS, MODEL B1027-201
Microbiology
209d
Cleared
Jan 14, 2010
ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE...
Chemistry
205d
Cleared
Dec 16, 2009
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
Microbiology
222d
Cleared
Nov 20, 2009
ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL
Chemistry
53d
Cleared
Oct 29, 2009
INNOVANCE D-DIMER, MODEL OPBP09
Hematology
121d
Cleared
Oct 23, 2009
MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
Microbiology
30d
Cleared
Oct 21, 2009
DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE,...
Immunology
84d
Cleared
Oct 09, 2009
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
Chemistry
165d
Cleared
Aug 14, 2009
ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
Chemistry
119d
Cleared
Aug 06, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Immunology
97d
Cleared
Jul 22, 2009
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
Microbiology
83d
Cleared
Jun 01, 2009
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
Toxicology
61d
Cleared
May 28, 2009
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
Hematology
339d
Cleared
May 26, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Immunology
113d
Cleared
May 08, 2009
ADVIA CENTAUR TSH3-ULTRA METHOD
Chemistry
135d
Cleared
Apr 29, 2009
DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION...
Immunology
55d
Cleared
Apr 27, 2009
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
Immunology
84d
Cleared
Apr 02, 2009
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL),...
Chemistry
136d
Cleared
Mar 30, 2009
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT,...
Toxicology
125d
Cleared
Mar 24, 2009
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN...
Immunology
123d
Cleared
Mar 24, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Immunology
90d
Cleared
Mar 13, 2009
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR,...
Immunology
109d
Cleared
Mar 11, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Immunology
121d
Cleared
Mar 11, 2009
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR,...
Chemistry
71d
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